Clavicle fixation system

ABSTRACT

Clavicle fixation devices and methods thereof. A clavicle fixation device includes an elongated plate extending between first and second ends, the elongated plate defining a plurality of spaced apart screw holes. At least one pair of relief cuts extends into the elongated plate on opposite sides thereof, the at least one pair of relief cuts axially positioned between a pair of the spaced apart screw holes and at least one pair of suture holes along opposite sides of the elongated plate, the at least one pair of suture holes axially positioned between a pair of the spaced apart screw holes. At least one pair of relief cuts is axially aligned with a pair of suture holes to define combined holes on opposite sides of the elongated plate.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.16/827,763 filed on Mar. 24, 2020 which is a divisional application ofU.S. patent application Ser. No. 15/808,113 filed on Nov. 9, 2017 whichis a continuation-in-part of U.S. application Ser. No. 15/719,633, filedSep. 29, 2017, which claims priority to U.S. provisional application No.62/469,813, filed Mar. 10, 2017, each of which is incorporated byreference herein in its entirety for all purposes.

FIELD OF THE INVENTION

The present disclosure is generally directed to surgical devices andmethods. More particularly, the present disclosure is directed to traumaplates, fasteners, intramedullary nails, systems, and methods designedto fix fractures, non-unions, and ligamentous injuries of the clavicleor the like.

BACKGROUND

The clavicle or collar bone is one of the most commonly broken bones inthe body. While some clavicle fractures heal with nonoperativemanagement, more recent studies have found that in cases of specificfracture patterns and locations, not all clavicle fractures behave thesame way.

The focus of treatment of middle third fractures remains nonoperative,although evidence is mounting in support of operative treatment fordisplaced midshaft clavicle fractures.

The incidence of nonunion of displaced distal third fractures is high,and current recommendations are to fix these injuries surgically.

Patients with the following injuries, for example, are often consideredfor operative intervention: complete fracture displacement, severedisplacement causing tenting of the skin with the risk of puncture,fractures with significant shortening, comminuted fractures with adisplaced transverse zed fragment, fractures with neurovascularcompromise, displaced medial clavicular fractures with mediastinalstructures at risk, polytrauma with multiple fractures, open fractures,fractures where the patient has an inability to tolerate closedtreatment, fractures with interposed muscle, established symptomaticnonunion, or concomitant glenoid neck fracture.

Additionally, evidence is mounting in support of operative treatment fordisplaced midshaft clavicle fractures, finding that operative repair forthese injuries provided better results than did nonoperative treatment.In several studies, outcomes with regard to the rate of successful boneunion, functional outcome, time required for patients to resume theirdaily activities, and overall patient satisfaction were superior in theoperative group than in nonoperative patients. There was alsosignificantly less posttraumatic clavicular shortening in the surgicalgroup.

With an increased consideration of operative repair, improved claviclefixation systems are desired.

SUMMARY

Clavicle bone plates, intramedullary clavicle nails, systems, andmethods of treatment are provided. The systems and devices may beparticularly suitable for fixation of the clavicle. Although generallydescribed with reference to the clavicle, it will be appreciated thatthe systems and devices may be adapted for use with any long bone, shortbone, flat bone, or the like.

In at least one embodiment, the present disclosure provides claviclefixation device includes an elongated plate extending between first andsecond ends and defining a central portion, a first end portion betweenthe central portion and the first end, and a second end portion betweenthe central portion and the second end. The elongated plate defines aplurality of spaced apart screw holes. At least one pair of relief cutsextends into the elongated plate on opposite sides thereof and areaxially positioned between a pair of the spaced apart screw holes. Atleast one pair of suture holes extends into the elongated plate alongopposite sides thereof and are axially positioned between a pair of thespaced apart screw holes.

In at least one embodiment, the present disclosure provides a claviclefixation device including an elongated plate extending between first andsecond ends, the elongated plate defining a plurality of spaced apartscrew holes. At least one pair of relief cuts extends into the elongatedplate on opposite sides thereof, the at least one pair of relief cutsaxially positioned between a pair of the spaced apart screw holes and atleast one pair of suture holes along opposite sides of the elongatedplate, the at least one pair of suture holes axially positioned betweena pair of the spaced apart screw holes. At least one pair of relief cutsis axially aligned with a pair of suture holes to define combined holeson opposite sides of the elongated plate.

In at least one embodiment, the present disclosure provides a method ofpreparing a clavicle fixation device which comprises an elongated plateextending between first and second ends, the elongated plate defining aplurality of spaced apart screw holes, wherein at least one pair ofrelief cuts extends into the elongated plate on opposite sides thereof,the at least one pair of relief cuts axially positioned between a pairof the spaced apart screw holes and at least one pair of suture holesalong opposite sides of the elongated plate, the at least one pair ofsuture holes axially positioned between a pair of the spaced apart screwholes; and wherein at least one pair of relief cuts is axially alignedwith a pair of suture holes to define combined holes on opposite sidesof the elongated plate. The method includes the step of bending theelongated plate in the anterior/posterior direction and/or in thecaudal/cranial direction at at least one combined hole pair such thatthe elongated plate has a contour which complements the contour of aclavicle anterior or superior surface.

Also provided are methods of treatment and kits including bone platesand/or intramedullary nails of varying shapes and sizes, bone anchors,fasteners, insertion tools, and other components for installing thesame.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide a furtherunderstanding of the present disclosure, are incorporated in andconstitute a part of this specification, illustrate aspects of thepresent disclosure and together with the detailed description serve toexplain the principles of the present disclosure. No attempt is made toshow structural details of the present disclosure in more detail thanmay be necessary for a fundamental understanding of the presentdisclosure and the various ways in which it may be practiced. In thedrawings:

FIGS. 1A and 1B are perspective views of anterior fixation plates inaccordance with embodiments of the present disclosure, each shownpositioned along a clavicle;

FIGS. 2A-2D are side elevation views of anterior fixation plates inaccordance with embodiments of the disclosure illustrating differentcontours;

FIGS. 3A and 3B are top plan views of the anterior fixation plates ofFIGS. 1A and 1B, respectively;

FIGS. 4A and 4B are front elevation views of the anterior fixationplates of FIGS. 1A and 1B, respectively;

FIGS. 5A and 5B are plan views of end portions of anterior fixationplates in accordance with embodiments of the disclosure;

FIG. 6 is a perspective view of an end tip of an anterior fixation platein accordance with an embodiment of the disclosure;

FIG. 7 is a perspective view of an anterior fixation plate in accordancewith an embodiment of the disclosure illustrating the rounded top andundersides thereof;

FIG. 8 is a perspective view of the underside of a central portion of ananterior fixation plate in accordance with an embodiment of thedisclosure;

FIG. 9 is a perspective view of the underside of an end portion of theanterior fixation plate of FIG. 8;

FIG. 10 is a top perspective view illustrating the cross-sectionalprofile of a fixation plate in accordance with an embodiment of thedisclosure;

FIG. 11 is a bottom perspective view illustrating the underside of thecross-sectional profile of FIG. 10;

FIG. 12 is a side perspective view of a portion of an anterior fixationplate in accordance with an embodiment of the disclosure illustratingthe side relief cuts thereof;

FIG. 13 is a plan view illustrating the side relief cuts of FIG. 12;

FIGS. 14A and 14B are perspective views of the anterior lateral fixationplates of FIGS. 1A and 1B, respectively;

FIG. 15A is a perspective view of an anterior midshaft fixation plate inaccordance with an embodiment of the disclosure;

FIGS. 15B, 15C and 15D are a top plan view, side elevation view and aperspective view, respectively, of another anterior midshaft fixationplate in accordance with an embodiment of the disclosure;

FIG. 16 is a plan view of a central portion of an anterior fixationplate in accordance with an embodiment of the disclosure;

FIG. 17 is a side perspective view of the anterior fixation plate ofFIG. 16;

FIG. 18 is a cross-sectional view of a portion of an anterior fixationplate in accordance with an embodiment of the invention illustrating ascrew extending through a dynamic compression plating slot thereof;

FIG. 19 is a cross-sectional view of a portion of an anterior fixationplate in accordance with an embodiment of the invention illustratingscrews extending through polyaxial holes thereof;

FIGS. 20A, 20B and 20C are perspective views of superior fixation platesin accordance with embodiments of the present disclosure, each shownpositioned along a clavicle;

FIGS. 21A and 21B are top and side elevation views of superior fixationplates in accordance with an embodiments of the disclosure illustratingdifferent contours;

FIGS. 21C, 21D and 21 E are top views of superior fixation plates inaccordance with an embodiments of the disclosure illustrating additionalcontours;

FIG. 21 F is a side elevation view and perspective view of a superiorfixation plate in accordance with an embodiment of the disclosureillustrating different contours;

FIG. 22 is a perspective of the superior fixation plate of FIG. 20;

FIG. 23 is a perspective view of another superior fixation plate inaccordance with an embodiment of the present disclosure;

FIGS. 24A, 24B and 24C are a perspective view, a top view, and a bottomperspective view of another superior fixation plate in accordance withan embodiment of the present disclosure;

FIGS. 25A, 25B, 26A and 26B are top and side perspective views,respectively, of end portions of superior fixation plates in accordancewith embodiments of the disclosure illustrating a plurality of screwsextending through the polyaxial holes thereof;

FIGS. 27A, 27B, 28A and 28B are top and bottom perspective views of aportion of the end of superior fixation plates in accordance withembodiments of the disclosure illustrating the k-wire/suture holesthereof;

FIGS. 29 and 30 are front perspective views of a hook plate inaccordance with an embodiment of the disclosure positioned relative aclavicle and AC joint, with FIG. 30 illustrating the clavicle and ACjoint transparently;

FIGS. 31A and 32A are top perspective views of the hook plate of FIG.29, with FIG. 32A illustrating the clavicle and AC joint transparently,FIGS. 31B and 32B are top perspective views similar to FIGS. 31A and 32Aillustrating a hook plate in accordance with another embodiment of thedisclosure;

FIGS. 33A, 33B and 33C are a perspective view, top view and sideelevation view of the hook plate of FIGS. 31B and 32B;

FIGS. 34A and 34B are perspective views of the hook portions of the hookplates in accordance with embodiments of the disclosure;

FIG. 35 is a perspective view of a straight fixation plate in accordancewith an embodiment of the invention;

FIG. 36 is a top view of the straight fixation plate of FIG. 35;

FIG. 37 is a side elevation view of the straight fixation plate of FIG.35;

FIG. 38 is a bottom perspective view of a portion of the straightfixation plate of FIG. 35;

FIG. 39 is an expanded top view of the straight fixation plate of FIG.35;

FIGS. 40A, 40B, 40C, 40D and 40E illustrated the position of claviclecommon fracture zones and the positioning of a plate in accordance withthe embodiment of the disclosure relative thereto.

FIG. 41 is a side elevation view of an intramedullary clavicle nail inaccordance with an embodiment of the invention;

FIG. 42 is a left side perspective view of the tip portion of theintramedullary clavicle nail of FIG. 41;

FIG. 43 is a right side perspective view of the tip portion of theintramedullary clavicle nail of FIG. 41;

FIG. 44 is a bottom perspective view of the tip portion of theintramedullary clavicle nail of FIG. 41; and

FIG. 45 is a side elevation view of the intramedullary clavicle nail ofFIG. 41 positioned within the intramedullary of a clavicle.

DETAILED DESCRIPTION

The aspects of the present disclosure and the various features andadvantageous details thereof are explained more fully with reference tothe non-limiting aspects and examples that are described and/orillustrated in the accompanying drawings and detailed in the followingdescription. It should be noted that the features illustrated in thedrawings are not necessarily drawn to scale, and features of one aspectmay be employed with other aspects as the skilled artisan wouldrecognize, even if not explicitly stated herein. Descriptions ofwell-known components and processing techniques may be omitted so as tonot unnecessarily obscure the aspects of the present disclosure. Theexamples used herein are intended merely to facilitate an understandingof ways in which the present disclosure may be practiced and to furtherenable those of skill in the art to practice the aspects of the presentdisclosure. Accordingly, the examples and aspects herein should not beconstrued as limiting the scope of the present disclosure, which isdefined solely by the appended claims and applicable law. Moreover, itis noted that like reference numerals represent similar parts throughoutthe several views of the drawings.

Orthopedic bone plates, intramedullary nails, systems, and methods oftreatment are provided. The bone plates and nails may be useful inrepair of the clavicle. Although further described with reference totreatment of the clavicle, it will be appreciated that the system anddevices may be adapted for use with any bones, including but not limitedto, the femur, tibia, humerus, fibula, ulna, radius, bones of the foot,bones of the hand, or the like.

Referring to FIGS. 1-19, anterior fixation plates 100 a-100 d inaccordance with various embodiments of the disclosure will be described.FIGS. 1a, 1b, 3a, 3b, 4a and 4b illustrate anterior fixation plates 100a, 100 b positioned along an anterior surface of a clavicle 10. Eachanterior fixation plate 100 a, 100 b includes an elongate body 102extending between opposed ends 101, 103 with an outer surface 105 and aninner, bone contacting surface 107.

Referring to FIGS. 2A-2D, the anterior plates 100 a, 100 a′, 100 b, 100b′ are anatomically contoured to fit along the curved anatomy of theanterior clavicle. The anterior plates 100 a, 100 a′, 100 b, 100 b′ areinterchangeable for left-side and right-side clavicles. As the curvatureof the bone varies between individuals, the anterior plates 100 a, 100a′, 100 b, 100 b′ are offered in multiple contours, with exemplarycontours illustrated in FIGS. 2A-2D. Each plate 100 a, 100 a′, 100 b,100 b′ includes a central portion 104 extending between end portions106, 108. Referring first to FIGS. 2A and 2B, the contour of the plate100 a, 100 a′ is defined by the angle α, β of the end portions 106, 108relative to the central portion 104 as well as the curvature R₁, R₂, R₃,R₄ of each end portion 106, 108. The angle α of plate 100 a may range,for example, from about 20-30°, about 20-25°, about 23-25°, or about24°. The angle β of plate 100′ may range, for example, from about30-40°, about 30-35°, about 33-35°, or about 34°. The radius R₁, mayrange, for example, from about 100-200 mm, about 120-160 mm, or about140 mm. The radius R₂ may range, for example, from about 10-100 mm,about 60-100 mm, or about 80 mm. The radius R₃ may range, for example,from about 50-150 mm, about 90-130 mm, or about 110 mm. The radius R₄may range, for example, from about 10-100 mm, about 30-70 mm, or about50 mm. In the illustrated embodiments, the angle α of plate 100 (forexample 24°) is smaller than the angle β of plate 100′ (for example 34°)and the radiuses R₁, R₂ (for example 140 mm, 80 mm) are larger than theradiuses R₃, R₄ (for example 110 mm, 50 mm). With the illustratedconfigurations, the plate 100 a of FIG. 2A is said to have a shallowconfiguration while the plate 100 a′ of FIG. 2B is said to have a deepconfiguration. Referring to FIGS. 2C and 2D, the plates 100 b, 100 b′have a longer length with the ends 106, 108 extending over a greaterarcuate length. Each arcuate length is defined by the arc of arespective ellipse. As in the previous embodiments, the plates 100 b,100 b′ may have varying radiuses to achieve a shallow configuration asin plate 100 b or a deep configuration as in plate 100 b′. The plates100 a, 100 a′, 100 b, 100 b′ may have various angles and radiuses orelliptical dimensions and are not limited to the illustrative examples.Selecting a contoured plate 100 a, 100 a′, 100 b, 100 b′ closelymatching the bone's contour minimizes plate prominence and irritationunder soft tissue.

Referring to FIGS. 3A-6, the anterior fixation plate 100 a, 100 b isfurther contoured in both width and cross-sectional thickness. In theillustrated embodiment, the plate 100 a, 100 b has a largestcross-sectional thickness T₁ in the central portion 104 and then tapersto smaller cross-sectional thickness T₂, T₃ in each end portion 106,108. The thicknesses T₂, T₃ in the end portions 106, 108 may be the sameor distinct from one another. As illustrated in FIGS. 5A, 5B and 6, theplate 100 a, 100 b may include additional taper 109 at the plate ends101, 103, beyond the last hole. The additional taper 109 aidssub-muscular insertion of the plate for minimally-invasive procedures.

The plate 100 a, 100 b also has a largest width W₁ in the centralportion 104 and then narrows to smaller widths W₂, W₃ in each endportion 106, 108. The widths W₂, W₃ in the end portions 106, 108 may bethe same or distinct from one another. Referring to FIG. 5A, in theplate 100 a, the end portion 108 narrows at different rates, with theportion 108 a closest to the central portion 104 narrowing more steeplythan the portion 108 b toward the end 103, which has a more gradualnarrowing. Referring to FIG. 5B, in the plate 100 b, the end portion 108narrows at a constant rate.

The plate 100 a, 100 b thicknesses and widths are selected such that theplate 100 a, 100 b optimally spans a common clavicle fracture zone.Image research study of clavicle fractures is used to identify the mostcommon fracture zones. For example, referring to FIGS. 40A, 40B and 40D,image studies may show that a common fracture zone 12 occurs at alocation which is about 42% of the length of the bone 10. Accordingly,the plates 100 are configured such that the central portion 104 willoverly the area at about 42% of the length of the bone 10 when the plate100 is attached to the bone 10. FIGS. 40C and 40E illustrate instanceswherein studies show a common fracture zone 12 at different positionsalong the bone 10, namely, at 35% of the bone length and 50% of the bonelength, respectively. Accordingly, the plates 100 are configured suchthat the central portion 104 will overly the area at about 35% of thelength of the bone 10 or 50% of the length of the bone when the plate100 is attached to the bone 10. The length, thicknesses and width ofeach plate portion 104, 106, 108 are selected such that the optimal spancomprises a thicker cross-sectional area and greater moment of inertiafor a distance appropriate to the extent of the fracture zone. At eitherend of the optimal span, where strength is less essential, the plate 100narrows in width and tapers lower in thickness. This narrowing and taperenables the plate 100 to be low-profile, minimizing prominence andirritation under soft tissue.

Referring to FIGS. 7-11, the plate 100 a, 100 b may also include arounded outer surface 105 and a rounded inner surface 107. The roundedsurfaces 105, 107 assist in keeping plate prominence to a minimum. Theinner surface 107 may further include cylindrical or ellipticalundercuts 112, 114 sweeping the length of the plate 100. The undercuts112, 114 reduce the contact surface of the plate 100 a, 100 b againstthe clavicle bone 10. This may reduce damage to the periosteum, preserveblood supply, reduce osteonecrosis, and speed fracture consolidation.

Referring to FIGS. 10 and 11, an exemplary undercut pattern isillustrated. The plate inner surface 107 has a curvature with a radiusof R_(A) and defines the bone contacting surface. The radius R_(A) issimilar to the radius of the clavicle bone surface. Each of theundercuts 112, 114 extends the length of the plate 100 and has a radiusR_(B), R_(C), respectively. The radiuses R_(B), R_(C) may be the same ormay be different from one another. The radiuses R_(B), R_(C) of theundercuts 112, 114 are smaller than the radius containing the plate/bonecontact surfaces R_(A). The undercuts 112, 114 reduce plate contact withthe bone surface while only minimally reducing cross-sectional strength.While two undercuts are illustrated, more or fewer undercuts, eithercircular or elliptical, may be utilized.

Referring to FIGS. 12 and 13, side relief cuts 116 extend into the body102 of the plate 100 a, 100 b along the sides thereof. In theillustrated embodiments, the relief cuts 116 are provided in opposedpairs on each side of the body 102, however, other configurations may beutilized. The relief cuts 116 are positioned between screw holes therebyreducing the moment of inertia between the screw holes to allowpreferential bending between holes, helping to minimize deformation ofthe screw holes. The illustrated relief cuts 116 have a rounded orsmooth configuration to minimize the risk of kinking or fracture. Asillustrated in FIGS. 1A, 4A and 14A, the relief cuts 116 in the plate100 a are present near the end portions 106, 108 of the plate 100 awhere contour customization by bending is the most likely to be desired,however, other configurations may be utilized. For example, in the plate100 b, as illustrated in FIGS. 1B, 4B and 14B, the relief cuts 116 arepresent in the central portion 104 as well as near the end portions 106,108 of the plate 100 b.

Referring to FIGS. 14A-19, the plates 100 a-100 d may be provided withvarious through holes, including oblong suture holes 120, round K-wireholes 126, dynamic compression plating (DCP) slots 130, and polyaxialholes 136. The oblong suture holes 120 are positioned along but inwardof the side edges of the plate body 102. The round K-wire holes 126 areprovided at each end 101, 103 of the plate 100, 100″ and may be providedat other more central areas, as shown in FIG. 14A. The oblong sutureholes 120 and the round K-wire holes 126 may be used as K-wire holes toallow provisional fixation of the plate 100, 100″ with K-wires.Additionally, the oblong suture holes 120 may be used for suture and anundercut 122 is aligned with each oblong suture hole 120 and extendsinto the inner surface 107 of the plate 100 a-100 d. The undercuts 122have a width that is wider than the width of the corresponding suturehole 120. The undercuts 122 enable free passage of suture underneath theplate 100, 100″ without interference at the plate/bone interface. Theundercuts 122 help reduce the moment of inertia between screw holes toallow preferential bending between holes, helping to minimizedeformation of screw holes. This is useful for plate contourcustomization. The undercuts 122 also serve to further reduce thecontact surface of the inner surface 107 of the plate 100 a-100 d. Theundercuts 122 may be co-located with relief cuts 116 and suture holes120.

In the illustrated embodiments, the oblong suture holes 120 have arounded triangular configuration and are positioned between screw holes130, 136. With this configuration, the oblong suture holes 120 reducethe moment of inertia between screw holes to allow preferential bendingbetween holes, helping to minimize deformation of screw holes. This isuseful for plate contour customization. While the oblong suture holes120 are illustrated with a rounded triangular configuration, otherconfigurations may be utilized, for example, elliptical, round, oval.

The oblong suture holes 120 also facilitate passage of suture/needles toserve as anchor points useful for reattachment and repositioning of softtissue damaged during surgery which may aid post-surgical soft tissuehealing. The oblong suture holes 120 also facilitate passage ofsuture/needles for cerclage techniques which may aid in reduction andfixation of bone fragments, particularly “butterfly” fragments on theinferior side of the bone. In the illustrated embodiment, the opposedsuture holes 120 on either side of the plate 100 a-100 d allow forcerclage running from one side of the plate, down under the bone, up tothe opposing suture hole, and potentially across again to theoriginating hole for successive loops. These opposing holes 120 also aidcerclage perpendicular to the plate trajectory. This is the optimalangle for applying force to reduce fragments toward the plate.

Referring to FIGS. 16 and 18, each DCP slot 130 has an oblongconfiguration with tapered end walls 132 and a central neutral headreceiving area 134. Contact of a screw head 133 with the tapered endwall 132 may cause medial-lateral motion of the plate 100 a-100 drelative to the bone to compress a bone fracture. Standard neutralplacement may also be achieved by positioning the screw head in thecentral neutral head receiving area 134. Compression or neutralplacement is typically achieved using a non-locking screw 131, forexample, a 3.5 mm non-locking screw. The DCP slot 130 also enablesoff-axis, or oblique, screw trajectories in the plane of the slot usingnon-locking screws. Cancellous screws enable oblique or neutral screwtrajectories through the DCP slot 130, useful for fragment capture orload neutralization across the fracture line.

The polyaxial holes 136 accept locking and non-locking screws, bothinserted within a cone of angulation, as illustrated in FIG. 18. Thepolyaxial holes 136 may be configured to accept different sized screws,for example, 3.5 mm screws at the midshaft end 101 of the plate 100 and2.5 mm screws at the far lateral end 103 of the plate 100. The nominaltrajectory of the far lateral holes assists in aiming screws to goodquality bone and away from the acromioclavicular joint space, asillustrated in FIG. 19.

As illustrated in FIGS. 14A-15C, the DCP slots 130 and polyaxial holes136 may be arranged in various configurations. In the anterior lateralplate 100 a illustrated in FIG. 14A, the DCP slots 130 and the polyaxialholes 136 alternate in the central portion 104 and the end portion 106while the end portion 108 includes consecutive polyaxial holes 136. Theanterior lateral plate 100 b illustrated in FIG. 14B is similar to theplate 100 a wherein the DCP slots 130 and the polyaxial holes 136alternate in the central portion 104 and the end portion 106 while theend portion 108 includes consecutive polyaxial holes 136, however theend portion 108 incudes additional polyaxial holes 136 compared to theprevious embodiment. In the anterior midshaft plate 100 c illustrated inFIG. 15A, the DCP slots 130 and the polyaxial holes 136 alternate overthe length of the plate 100 c. In the anterior midshaft plate 100 dillustrated in FIGS. 15B-15D, the DCP slots 130 and the polyaxial holes136 generally alternate over the length of the plate 100 d with theexception of an additional DCP slot near the end 108. Otherconfigurations other than those illustrated may also be utilized.

Referring to FIGS. 20A-28B, superior fixation plates 200 a-200 d inaccordance with various embodiments of the disclosure will be described.FIGS. 20A-20C illustrate superior fixation plates 200 a, 200 bpositioned along a superior surface of a respective clavicle 10. Thesuperior fixation plates 200 a-200 d are similar to the anteriorfixation plates described above and each includes an elongate body 202extending between opposed ends 201, 203 with an outer surface 205 and aninner, bone contacting surface 207. The superior fixation plates 200a-200 d may include any of the features described with respect to theanterior plates, including rounded outer and inner surfaces 205, 207,undercuts 112, 114 on the inner surface 207, side relief cuts 116,oblong suture holes 120, undercuts 122, round K-wire holes 126, DCPslots 130 and polyaxial holes 136.

Referring to FIGS. 21A-21F, the superior plates 200 a-200 c areanatomically contoured to fit along the curved anatomy of the superiorclavicle. The superior plates 200 a-200 c are not interchangeable forleft-side and right-side clavicles, but instead are configured foreither the left-side or right-side clavicle. As the curvature of thebone varies between individuals, the superior plates 200 a-200 c areoffered in multiple contours, with exemplary contours illustrated inFIGS. 21A-21F. Each plate 200 a-200 c′ has an “S” curvature in the A/Pdirection and a slight bow in the caudal/cranial direction. Plates 200a-200 c′ following contours with less (FIG. 21A and FIG. 21C) or more(FIG. 21B or FIG. 21D) “S” curvature may be referred to as “shallow” or“deep” contoured plates, respectively. As illustrated, the plates 200a-200 c′ may have various angles and radiuses or elliptical dimensions,however, the configurations are not limited to the illustrativeexamples. Selecting a contoured plate 200 a-200 c′ closely matching thebone's contour minimizes plate prominence and irritation under softtissue.

Furthermore, as shown in FIGS. 22-24C, the plates 200 a-200 d may havevarying lengths with varying hole configurations. FIGS. 22 and 23 showsuperior lateral plates 200 a, 200 c having a length longer than thelength of the superior midshaft plate 200 d illustrated in FIGS.24A-24C. Each of the plates 200 a-200 d generally include alternatingDCP slots 130 and polyaxial holes 136, however, other holeconfigurations may be utilized. The superior fixation plates 200 a and200 b include an additional hole, namely, a sliding slot 240. Referringto FIGS. 25A-25B, the sliding slot 240 has a rectangular configurationand is configured to receive a sliding slot screw 241 with a wide head242. The shaft of the screw 241 has a diameter smaller than the width ofthe slot 240 while the head 242 has a diameter greater than the width ofthe slot 240. The slot 240 allows fine bi-directional adjustments of theplate 200 while maintaining provisional placement. The screw 241 mayalso be utilized for permanent fixation. The sliding slot screw and allother screws in the set may also be utilized as a stand-alone fragmentcapture/lag screw.

Referring to FIGS. 22 and 25A-28B, the lateral superior fixation plates200 a, 200 b include a lateral extension 210. Such a plate 200 a, 200 bmay be used, for example, to fix fractures occurring at the far lateralend of the clavicle 10. The lateral extension 210 contains a pluralityof polyaxial holes 136 that allow many diverging screw trajectories tosecure the plate in this thin, metaphyseal bone region, as shown inFIGS. 26A-B. The polyaxial holes 136 accept locking and non-lockingscrews. For ease of surgical planning, nominal, diverging and convergingtrajectories are intended to secure in regions of dense bone and awayfrom the acromioclavicular joint space.

The lateral extension 210 also defines a plurality of oblong sutureholes 120 similar to those in the shaft of the plate 200 a, 200 b. Thelateral extension suture holes 120 have undercuts 122′ to allow freepassage of suture underneath the plate 200, however, the width of theseundercuts 122′ is limited to the width of the suture hole 120.

Referring to FIGS. 29-34B, superior hook plates 200 e, 200 f will bedescribed. The body 202 of the superior hook plates 200 e, 200 f issimilar to the previous embodiments except that a hook member 250extends from the end 201′ of the plate 200 e, 200 f Such hook plates 200e, 200 f may, for example, be utilized to aid healing ofacromioclavicular (AC) joint separations with clavicular displacement.The hook member 250 includes an extension portion 251 which extends fromthe end 201′ of the plate 200 e, 200 f to the postero-lateral side ofthe AC joint 12. A descending arm 252 extends inferiorly from theextension portion 251 to a given depth from which a lateral arm 254angles laterally to hook underneath the acromion 14. This constrainssuperior displacement of the clavicle 10. The hook plates are offeredwith various descending arm 252 lengths to accommodate diverse shoulderand injury anatomies.

In each of the illustrated embodiments, the lateral arm 254 fans outinto a widened head 256, 256′ that increases contact surface areabetween the hook member 250 and the underside of the acromion 14. Thewidened head 256, 256′ may have various shapes, with FIGS. 34A and 34Billustrating exemplary shapes. The widened head 256 in FIG. 34A has acurved spatula shape while the widened head 256′ in FIG. 34B has acurved spoon shape, each with smoothed edges. The widened heads 256,256′ help to reduce painful irritation, bony erosion, and incidentalfracture on the underside of the acromion 14 by distributing the load toa wider area. The smoothed edges of the widened head 256, 256′ alsofacilitate insertion into this soft tissue space and eventual removal,and while in place minimizes irritation to the rotator cuff and othersoft tissues.

Referring to FIGS. 35-39, a straight fixation plate 300 in accordancewith various embodiments of the disclosure will be described. Thestraight fixation plates 300 is similar to the anterior and superiorfixation plates described above and includes an elongate body 302extending between opposed ends 301, 303 with an outer surface 305 and aninner, bone contacting surface 307. The straight fixation plates 300differs from the previously described plates in that the straightfixation plate 300 is not pre-bent, but instead may be configured to bebent to an appropriate curved configuration complementing the curvatureof the bone to which it will be attached. That being said, the straightfixation plate 300 may include any of the features described withrespect to the anterior and superior plates, including a wider and/orthicker central portion 304, rounded outer and inner surfaces 305, 307,undercuts 112, 114 on the inner surface 307, side relief cuts 116,oblong suture holes 120, undercuts 122, round K-wire holes 126, DCPslots 130 and polyaxial holes 136. The straight fixation plate 300 mayhave varying lengths with varying hole configurations. The plate 300generally includes alternating DCP slots 130 and polyaxial holes 136,with the illustrated embodiments having an additional DCP slot 130 inthe central region. However, other hole configurations may be utilized.

The straight fixation plate 300 does not have alternating relief cutsand suture holes like in the previous embodiments, but instead, theholes provide a combined relief cut and suture hole with undercuts. Asseen in FIGS. 38 and 39, each combined hole 325 includes a relief cut316 and undercut 322 into the body 302 in alignment with the oblongsuture hole 320. As with the previous embodiments, the relief cutportions 316 are positioned between screw holes thereby reducing themoment of inertia between the screw holes to allow preferential bendingbetween holes, helping to minimize deformation of the screw holes. Theillustrated relief cuts 316 have a rounded or smooth configuration tominimize the risk of kinking or fracture. Similar to the previousembodiments, the undercuts 322 also help reduce the moment of inertiabetween screw holes to allow preferential bending between holes, helpingto minimize deformation of screw holes.

Furthermore, the combined holes 325 provide further assistance withbending. More specifically, during surgeon contouring of the plate 300 bby bending in the caudal/cranial direction, as illustrated in FIG. 40,the side relief cut 316 of the combined hole 325 on the compression side(bottom side in FIG. 40) will deform, or further “crimp”, inwards. Theouter edge of the suture hole 320 on the tension side (upper side ofFIG. 40) contains more material than is necessary for this span. Thistension side will “uncrimp” or deform by necking outwards, resulting ina straighter outer plate edge. Bending to evident failure of the neckedmaterial on the tension side may be calibrated to serve as an indicatorof excessive bending of the plate 300, making it unusable. Theintentional regions of deformation during bending created by thecombined holes 325 may diminish bending at undesirable regions at thescrew holes.

Referring to FIGS. 41-45, an intramedullary clavicle nail 400 inaccordance with an embodiment of the disclosure will be described. Aplurality of different sized nails 400, for example, having diameters of3.0, 3.5, 4.0, 4.5, and 5.0 mm, may be provided as a set. The nails 400enable minimally invasive treatment of select clavicle fractures.Advantages of this technique are much less incision and scarring, andoften elimination of soft tissue prominence.

Each nail 400 includes an elongated body 402 extending from a trailingend 401 to a medial, leading end 403. The nail body 402 has apre-contoured configuration with anatomically appropriate radius R_(M)at the medial, leading end 403. The body 402 transitions to a straightregion at the trailing end 401. As shown in FIG. 45, upon insertion, thetrailing end 401 of the nail 400 exits the posterolateral side of theclavicle 10. The nail 400 is then cut to length and tamped below thebone surface.

Referring to FIGS. 42-44, the leading end 403 of the nail 400 has apointed shape with flats 405 on each side of a rounded tip 407. Therounded tip 407 extends to a wide underside 409. The pointed shape helpsto advance the nail 400 in the medullary canal with minimalpre-drilling, while the wide underside 409 of the tip offers some widthto rest against the canal wall. Such resistance helps to provide somerotational stability to maintain the orientation of the pre-curved nailwith the restored anterior bone curvature.

The orthopedic bone plates, intramedullary nails, and systems may beparticularly useful in in the treatment of the clavicle. The devices maybe provided with anatomic shapes suitable for fixation at distinctregions of the clavicle. It is envisioned, however, that the features ofone embodiment may be combined with features of another embodiment andthe disclosure and associated technology can encompass other embodimentsnot expressly shown or described herein. It will also be appreciatedthat although generally described with reference to the clavicle, itwill be appreciated that the systems and devices may be adapted for usewith any long bone, short bone, flat bone, or the like.

While the present disclosure has been described in terms of exemplaryaspects, those skilled in the art will recognize that the presentdisclosure can be practiced with modifications in the spirit and scopeof the appended claims. These examples given above are merelyillustrative and are not meant to be an exhaustive list of all possibledesigns, aspects, applications or modifications of the presentdisclosure.

What is claimed is:
 1. A clavicle fixation system comprising: anintramedullary clavicle nail having an elongated body extending from atrailing end to a medial, leading end; an elongated plate extendingbetween first and second ends and defining a central portion, a firstend portion between the central portion and the first end, and a secondend portion between the central portion and the second end, theelongated plate defining a plurality of spaced apart screw holes,wherein at least one pair of relief cuts extends into the elongatedplate on opposite sides thereof, the at least one pair of relief cutsaxially positioned between a pair of the spaced apart screw holes and atleast one pair of suture holes along opposite sides of the elongatedplate, the at least one pair of suture holes positioned between a pairof the spaced apart screw holes.
 2. The clavicle fixation systemaccording to claim 1 wherein an undercut in an inner surface of theelongated plate is aligned with each suture hole.
 3. The claviclefixation system according to claim 2 wherein at least a portion of theundercuts have a width larger than a width of the corresponding suturehole.
 4. The clavicle fixation system according to claim 1 wherein atleast one pair of relief cuts is axially aligned with a pair of sutureholes to define combined holes on opposite sides of the elongated plate.5. The clavicle fixation system according to claim 1 wherein are aplurality of combined hole pairs are defined along the elongated plate.6. The clavicle fixation system according to claim 1 wherein theelongated plate has an initial contour which complements the contour ofa clavicle anterior or superior surface.
 7. The clavicle fixation systemaccording to claim 1 wherein the elongated plate has an initial unbentflat contour.
 8. The clavicle fixation system according to claim 1wherein the second end portion narrows moving from the central portionto the second end.
 9. The clavicle fixation system according to claim 1wherein the first end portion narrows at at least two different angles,with a first subportion closer to the central portion narrowing at asteeper angle than a second subportion closer to the first end.
 10. Theclavicle fixation system according to claim 1 wherein each of the endportions tapers from a maximum thickness adjacent the central portion toa reduced thickness adjacent the respective end.
 11. The claviclefixation system according to claim 4 wherein the central portion issized such that the central portion overlies a common clavicle fracturezone which is determined based on image research study of claviclefractures.
 12. The clavicle fixation system according to claim 1 whereinthe elongated plate defines an outer surface and an inner surface and atleast the inner surface has a rounded configuration.
 13. The claviclefixation system according to claim 12 wherein at least one elongatedundercut is defined along the inner surface extending between the firstand second ends, the elongated undercut having a radial or ellipticaldimension smaller than a radial or elliptical dimension of the innersurface.
 14. The clavicle fixation system according to claim 12 whereinat least two elongated undercuts are defined along the inner surfaceextending between the first and second ends, each elongated undercuthaving a radial or elliptical dimension smaller than a radial orelliptical dimension of the inner surface.
 15. The clavicle fixationsystem according to claim 1 wherein the screw holes include polyaxialholes and dynamic compression plating slots.
 16. A clavicle fixationsystem comprising: an elongated plate extending between first and secondends, the elongated plate defining a plurality of spaced apart screwholes, an intramedullary clavicle nail having an elongated bodyextending from a trailing end to a medial, leading end; wherein theleading end of the nail has a pointed shape with flats on each side of arounded tip and the rounded tip extends to a wide underside. wherein atleast one pair of relief cuts extends into the elongated plate onopposite sides thereof, the at least one pair of relief cuts axiallypositioned between a pair of the spaced apart screw holes and at leastone pair of suture holes along opposite sides of the elongated plate,the at least one pair of suture holes axially positioned between a pairof the spaced apart screw holes; and wherein at least one pair of reliefcuts is axially aligned with a pair of suture holes to define combinedholes on opposite sides of the elongated plate.
 17. The claviclefixation system according to claim 1 wherein an undercut in an innersurface of the elongated plate is aligned with each suture hole andforms a portion of the combined hole.
 18. The clavicle fixation systemaccording to claim 16 wherein the elongated plate has an initial unbentflat contour.
 19. The clavicle fixation system according to claim 16wherein a portion of the elongated plate between a relief cut and asuture hole of a combined hole is configured to stretch and straightenwhen a sufficient tension force is applied to the elongated bodyproximate the combined hole.
 20. The clavicle fixation system accordingto claim 16, wherein the an intramedullary clavicle nail is configuredto provide rotational stability to maintain the orientation of thepre-curved nail with the restored anterior bone curvature.